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Behavioral Intervention
PASAT for Fibromyalgia
N/A
Recruiting
Led By Roland Staud, MD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Healthy, pain-free age and sex matched controls without chronic pain
Individuals diagnosed with FM will have pain of > 3 months and meet the 1990 and 2011 Diagnostic Criteria for FM (ACR)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0.5 hours
Awards & highlights
Study Summary
This trial is designed to see if a treatment to stop the central sensitization will lessen the pain of FM.
Who is the study for?
This trial is for individuals diagnosed with Fibromyalgia (FM) who have experienced pain for more than 3 months and meet specific diagnostic criteria. Healthy people without chronic pain can also join as controls. Participants should not have chronic diseases or significant vision loss, and FM patients must pause their medications for at least a day before the visit.Check my eligibility
What is being tested?
The study is testing how people with FM respond to a Paced Auditory Serial Addition Task (PASAT), which may help understand central hypersensitivity—a key mechanism in FM that relates to abnormal pain perception.See study design
What are the potential side effects?
Since PASAT is a non-invasive cognitive task involving listening and adding numbers, it does not have typical drug side effects. However, participants might experience mental fatigue or stress during the task.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am healthy, without chronic pain, and match the age and sex criteria.
Select...
I have been diagnosed with fibromyalgia and have had pain for more than 3 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0.5 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0.5 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Verbal Pain Ratings of Painful Heat and Pressure Stimuli using a Numerical Pain Scale from 0 - 100
Visual Evoked Potentials (VEP) During Flicker
Secondary outcome measures
Response to 2011 Fibromyalgia Criteria Questionnaire
Response to the Center for Epidemiological Studies (CES-D) Depression Questionnaire
Trial Design
1Treatment groups
Experimental Treatment
Group I: Effects of PASAT on Sensory TestingExperimental Treatment1 Intervention
After baseline evaluation of light and pain sensitivity FM subjects and controls will undergo the PASAT task. This task consists of responding to a rapid presentation of numbers by ear phones. Subjects are asked to add each 2 consecutive numbers and provide a response each time the sum is equal to 13. This test will last several minutes and delivered at increasing speed.
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Who is running the clinical trial?
University of FloridaLead Sponsor
1,343 Previous Clinical Trials
716,326 Total Patients Enrolled
7 Trials studying Fibromyalgia
736 Patients Enrolled for Fibromyalgia
Roland Staud, MDPrincipal InvestigatorUniversity of Florida
4 Previous Clinical Trials
343 Total Patients Enrolled
4 Trials studying Fibromyalgia
343 Patients Enrolled for Fibromyalgia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing to stop my fibromyalgia medication for at least one day before my visit.I have a long-term illness like cancer or diabetes.I am healthy, without chronic pain, and match the age and sex criteria.I have been diagnosed with fibromyalgia and have had pain for more than 3 months.My family has a history of epilepsy triggered by lights.
Research Study Groups:
This trial has the following groups:- Group 1: Effects of PASAT on Sensory Testing
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Fibromyalgia Patient Testimony for trial: Trial Name: NCT04415866 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are individuals above the age of 35 eligible for this medical experiment?
"Individuals who meet the age criteria of being 18 and younger than 70 years old are welcome to join this medical trial."
Answered by AI
Are there opportunities for individuals to join this research initiative?
"Per the information provided by clinicaltrials.gov, this medical trial is actively looking for suitable applicants. The study was first posted on August 28th 2020 and last modified on November 15th 2021."
Answered by AI
What demographic is most suitable for inclusion in this medical research?
"To be eligible to join this clinical trial, patients must have fibromyalgia and reside between 18-70 years of age. The research team is seeking a sample size of 100 individuals."
Answered by AI
How many participants is this clinical trial recruiting?
"Affirmative, the clinicaltrials.gov portal demonstrates that this research project is actively seeking patients since it's original posting on August 28th 2020 and last alteration made November 15th 2021. At present, 100 subjects must be recruited from a single study site."
Answered by AI
Who else is applying?
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What state do they live in?
Florida
What site did they apply to?
University of Florida
How many prior treatments have patients received?
1
What questions have other patients asked about this trial?
How often would I need to travel to Gainesville? Will I have to stay in Gainesville ?
PatientReceived 2+ prior treatments
Why did patients apply to this trial?
I’m disabled with fibromyalgia and was prescribed duolextine which didn’t help too much for me , so im hoping not only to find a helpful option for me but help others with fibromyalgia have more than just a low dose depression medication to help .
PatientReceived 2+ prior treatments
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